System for tracking biological samples

ABSTRACT

Systems, methods, and apparatus are described for the handling of biological specimens for analysis. The systems, methods and apparatus are designed to reduce errors in misidentification, incorrect processing, and recordkeeping and reporting. The systems, methods, and apparatus can also provide real time tracking of samples at any stage, from collection to processing to analyzing to storage.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of priority under 35 U.S.C. §119(e)to U.S. Provisional Application No. 60/332,948, filed Nov. 13, 2001, thecontents of which are incorporated by reference in its entirety for allpurposes.

TECHNICAL FIELD

This invention relates to the field of laboratory science and moreparticularly to the systems, methods and apparatus that can be used inthe laboratory.

BACKGROUND

Advances in science have made it possible to extract a wide variety ofinformation about an individual from a biological sample obtained fromthat individual. For example, it can assess the health, identifypossible future health issues, and provide the genetic makeup of theindividual. The results of any analysis, however, loose much of theirbeneficial qualities when the analysis is attributed to the wrongindividual or if the sample is processed incorrectly.

Much, if not all, of these analyses are processed in laboratories. Thelaboratory usually obtains its samples from institutions, such as thehospital, clinic, or police, and from individuals, such as samples sentto it from individuals using, for example, a Home HIV test kit. In theselaboratories, many samples are processed daily where they may passthrough many sets of hands and potentially be subjected to manydifferent tests. Each time a sample is handled, there is the potentialfor an error to occur. In many cases, a human operator is the source ofthe error. For example, in the collection of the sample, the sampleshould be clearly identified, e.g., from whom the sample was obtained.Samples, however, once removed from their natural environment, such asan individual's person, tend to look very similar to other samples oflike kind. Because of this, mix-ups have been known to happen when theinformation was incorrectly transcribed, labels were placed on the wrongsamples, or the identifying information was inadvertently omitted or wasincomplete. Moreover, errors can occur in the processing steps as well,such as the wrong reagents being used or the wrong tests beingperformed. It is, therefore, desirable that laboratories implementsystems, methods, and apparatus for maintaining the fidelity of theirwork, i.e., the proper analysis on the right sample and being able toreport the same to the person who ordered the test.

To prevent errors of this kind, elaborate and costly systems ofpaperwork are used. Current systems may also use barcodes to identifythe samples, such as patient information, as well as barcodes to carryother information, such as instructions about tests to be run. Often,this leads to a need to use multiple barcodes, each directing a specificfunction or holding information related to the sample. Because of thelimited space available for these barcodes on sample containers or ofthe risk of confusion, one barcode may need to be placed over another inorder to run the slide on more than one test. Alternatively, the oldbarcodes can be removed; however, it must be done without removing thebarcode holding needed information, such as the patient information.Moreover, since most barcodes look similar, the more widespread the useof barcodes for each specific task or bit of information, the greaterthe likelihood of placing the wrong barcode on a sample, possiblymisidentifying the sample and/or providing incorrect instructions forhandling the sample.

Once a sample is collected, it is labeled, or otherwise identified, andsent to a laboratory for further processing. For example, in a hospitalsetting, a health care provider will collect samples from a patient.These samples might be biopsies (pieces of tissue removed surgically) orother samples from a person including samples of blood, urine, stool,scrapings from the skin, or any other location, hair etc. Typically oneor more samples are bagged, labeled and sent to a laboratory with a workorder that specifies what diagnostic tests are to be performed on them.The laboratory may be in the same building as where the sample wascollected or it may be in another facility or even in another country.The laboratory may even forward the sample or a portion of the sample toyet another laboratory to do tests it cannot perform.

Once the sample arrives at the laboratory to be processed, the sample isprepared for analysis. For example, the sample can be taken to agrossing station. At the grossing station, the sample is removed fromits container and the desirable portions of the sample can be extractedand placed in the appropriate setting for further processing. Forexample, the portions can go into small baskets called cassettes, whichare used to carry the samples while they are fixed and embedded in wax.Once embedded, the samples can be sliced on a microtome and placed onslides. Since the slices are very thin (microns) many slides canpotentially be made from one cassette. While slides are described, otherreceptacles for holding the sample are used in the laboratory, and theyare contemplated for use herein, for example, tubes, cuvettes, biochips,and microplates, to name just a few. In each case, the source of theextracted portions of the sample must be correctly identified.

From here, the slides with the sample may go on to be specificallytreated for the test to be run on it, such as staining with reagents.The types of reagents used will depend upon the test that is to beperformed. Slides can be stained with a variety of chemicals that willmake relevant cells, germs or other structures visible. Once the slidesare processed, they can be read by an automated microscope, such as anACIS (Automated Cell Image System) or by an individual through amicroscope. A pathologist can examine the slide or the image of theslide and issue a diagnostic report that can be sent back to theclinician. Throughout this process, the user should ensure that all theslides are identified properly and that the proper test is beingperformed.

A fluid sample can be processed in a similar manner except that, insteadof the grossing and microtome steps, the cells in the sample can be spundown with a centrifuge and transferred to a slide. Smears may be applieddirectly to a slide by hand. There are a number of other patented andnon-patented methods of getting cells onto a slide that could be used inconjunction with the system described herein.

SUMMARY

In one general aspect, the invention contemplates a laboratory or anetwork of laboratories equipped with readers (scanners) such as barcodereaders, magnetic strip readers, keyboards, or a similar device that can“input” data directly or indirectly into a computer or computer system,such as Optical Character Recognition (OCR) readers. It is envisionedthat these scanners can be located at desired area in the laboratory orthroughout the facility, e.g., at one or more of the following areas,including but not limited to, the grossing stations, microtome, reagentdispensing stations, automated cell image analysis stations, or storageareas.

In another general aspect, the samples are assigned a unique identifiercomposed of numbers, letters, and/or symbols. The identifier can be inhuman readable text and/or computer readable text. In one embodiment,the identifier is a universal unique identifier (UUID). Theseidentifiers are unique across both space and time. Use of UUIDs does notrequire a registration authority for each identifier; instead, it uses aunique value over space for each UUID generator. Methods and algorithmsfor generating unique identifiers are known in the art, for example,UUIDLib is a Macintosh shared library that generates UUID identifiers.Global unique identifiers (GUID) are used by Microsoft to identifyanything related to its system. One source of information about uniqueidentifiers is the world wide web. The unique identifier can be read bya human and/or by a computer (e.g., scanners). In other embodiments, theidentifiers are generated from one source that dispenses identifierssequentially. In still other embodiments, algorithms used in computersgenerate a unique 128 bit number. Other methods of generating a uniqueidentifier are known to those skilled in the art.

Once assigned, the unique identifier remains associated with theparticular sample. Other samples derived from the original sample, suchas when the sample is being processed at the grossing station, areassigned their own unique identifier. In one embodiment, the uniqueidentifier is merely an identifier. In another embodiment, the uniqueidentifier can also provide information about the identifier, such asthe location of where and/or when the identifier was assigned, basedupon a characteristic of the identifier. For example, identifiers thatbegin with 01 can be designated to have originated from a particularfacility. In certain embodiments, the identifier does not hold anyinformation pertaining to the sample. In other words, the identifierdoes not hold any information about the source of the sample, the teststo be run on it, or what other samples may be related to it. The uniqueidentifier can be read by scanners or otherwise inputted into acomputer, such as by hand. Once in the computer, the information can betransmitted to a database.

In another general aspect, a central database can be utilized to houseall the information associated with the sample. The central database canstore any and all information about the sample, source information, thetests to be performed, the results obtained from the tests, and thelocation of the sample, to name just a few examples of the type ofinformation. The data in the central database can be updated each timenew information is received. In certain embodiments, the centraldatabase receives and stores information about the sample, such as thename of the patient (source) and other identifying information, type ofsample, when collected, and who collected it. The central database canalso receive and store information about what tests are to be performed.It can also receive and store information about when it was checked intothe lab. The central database can also receive and store informationabout how the sample was processed, what reagents were used and when itwas done, and whether there are other samples prepared from the originalsample and information relating to them, or otherwise linking the dataabout the original sample and the data from all samples derived from it.The central database can receive and store the results of the tests. Thecentral database can also receive and store information about additionaltests to be run or changes to existing orders. The central database canalso allow approved users to access this information. In certainembodiments, the data can be accessed from a terminal in close proximityto the laboratory or the database, or from a remote location, over theLAN, WAN, VPN or the world wide web.

In another general aspect, the central database may be in communicationwith the readers or scanners for inputting the unique identifies, suchas the barcode readers. The central database may be in communicationwith the equipment in the laboratory, such as the microtome, centrifuge,reagent dispensers, and automatic image analyzer, to name just a fewpieces of equipment found in laboratories. The readers or scanners mayalso be in communication with the equipment, so that all three,scanners, equipment, and the central database are in communication witheach other.

In another general aspect, the invention contemplates a computer systemincluding a database having records to the identity of a biologicalsample collected from a subject and the identity of a diagnosticanalysis to be performed on the biological sample and a remote userinterface, such as readers, scanners, display screens, printers andcomputer terminals, capable of receiving and/or sending the records, foruse in matching the biological sample with the diagnostic analysis to beperformed on the biological sample.

In another general aspect, the invention contemplates acomputer-assisted method for processing a biological sample including:using a programmed computer including a processor, an input device, andan output device, including inputting into the programmed computer,through the input device (readers, scanners, mouse, keyboard), dataincluding the identity of a biological sample collected from a subjectand the identity of a diagnostic analysis to be performed on thebiological sample; determining, using the processor, the parameters ofthe diagnostic analysis; and outputting, to the output device, displayscreens or printers, the results of the diagnostic analysis.

In another general aspect, the invention includes methods for theautomated analysis of a biological sample, including the steps of:providing a user with a mechanism for electronically communicating theidentity of a biological sample collected from a subject and theidentity of a diagnostic analysis to be performed on the biologicalsample; providing the biological sample with a unique identifier;providing the diagnostic analysis with a unique identifier; optionallyproviding the user with an opportunity to communicate a desiredmodification to the diagnostic analysis; allowing the user to transmitany of the above identified information to a server; allowing a seconduser to obtain the information from the server; correlating theinformation with the biological sample; performing the diagnosticanalysis on the biological sample; and inputting into a programmedcomputer, through an input device, data including the results of thediagnostic analysis.

In another general aspect, the invention contemplates methods ofselecting a therapy for the patient based upon: obtaining a patientsample from a caregiver; identifying a diagnostic profile to beperformed on the sample; providing a caregiver with a mechanism forelectronically communicating the identity of the biological samplecollected from the patient and the identity of the diagnostic profile tobe performed on the biological sample to a server, wherein the patientand profile are given a unique identifier; and allowing a second user toobtain the information from the server. A diagnostic profile may includea series of tests to be run on a particular sample.

In another general aspect, equipment useful for the system can include agrossing station that can read the barcode, or otherwise input theidentifier into the system. For example, a scanner reads the barcode ona sample bag and a list of tests to be done on the sample, to provideguidance to the pathologist doing the grossing, is displayed on ascreen. It may also be able to print out the barcodes for theappropriate number of cassettes, sample tubes, or other sample holders.If the cassettes and tubes are prelabled with a barcode, the pathologistcan scan the labels to associate the barcodes with the cassettes ortubes of samples. This method allows for the automatic entry ofinformation to the database to maintain the linkage between the patientand sample and the intermediate sample carriers (cassettes and tubes).

Other equipment includes a microtome with a scanner that can read abarcode or other identifying mark. The scanner can read the barcode onthe cassette or tube (i.e., the block of sample) and allow the databaseto transmit to the pathologist or technician information about whattests are to be performed on this block of sample and/or how many slidesare to be prepared from the block of sample. It can then print out therequired number of barcodes for each of the slides to be prepared. Anautostainer and an automated microscope that can read the identifier andextract information from the database as well as transmit information tothe database are contemplated as well.

The scanner, or similar device to input the identifier, such as abarcode reader, can be a component separate from the laboratoryequipment or it can be integrated into the laboratory equipment. Even ifthe scanner is a component separate from the equipment, it may still bein communication with the equipment.

In still another aspect, a sample is assigned a unique identifier. Inone embodiment, the unique identifier is in the form of a barcode.Information related to the sample is received by the central databaseand associated with the unique identifier. The sample is sent to thelaboratory for processing. The laboratory is equipped with scanners forinputting the unique identifier, in this case barcode readers. At thelaboratory, the user may scan the barcode of the sample to log in whenthe sample arrived in the laboratory. This information is received andstored by the central database. The user may take the sample to thegrossing station. At the grossing station, the user may scan the barcodeinto a barcode reader. The unique identifier is received by the centraldatabase and it is noted that the sample is at the grossing station at aparticular time. The database may also transmit to the user, for exampleon a display panel at the grossing station, information about how thesample is to be prepared.

The sample may then arrive at the microtome. The identifier of thesample is scanned, and the time and location is received by the centraldatabase. The central database can then transmit more information aboutprocessing the sample. For example, an order in the central database maystate that five different slides of the sample are to be prepared fromthe original sample. There is, of course, no limitation on the number ofslides that can be prepared. The central database may transmit thisinformation to the user at the grossing station and may evenautomatically print out labels with unique identifiers to affix to eachof the five slides with the biological sample, or the system may utilizeanother means of affixing the unique identifier to the slide, such as byencoding it by laser, stamping it, or encoded magnetic strip.Alternatively, the user may place the samples on slides already assigneda unique identifier. The central database stores information about thenew samples (e.g., that the samples associated with the new fiveidentifiers are derived from the original sample, when they wereprepared, and other useful information). This recordkeeping can be donewith very little input from the user.

The slides can now be prepared for their specific test. The centraldatabase stores the information about how the sample is to be preparedand what tests are to be run on them. At each station, e.g., samplefixer, reagent dispenser, or analyzer, the sample can be scanned. Thiswould log in the sample providing information such as location and timeto be stored in the central database. It can also ensure that the slideis being processed properly. For example, if the sample is at the wrongstation, there might be a display indicting such, the station may refuseto process the slide, and/or the information is logged so that onelooking at the history of the slide would know where the error occurred.All this can be recorded without the need for the user to take anynotes.

Once the slide is processed and the test results transmitted to thecentral database, the slides may then be put aside for storage. At thestorage area, the user can scan the slide to log it in, providing a timeand location for the slide in the central database, and set it aside. Ifa loose slide is found, the unique identifier can be scanned into thesystem to allow the central database to transmit the identifyinginformation back to the user, as well as logging in the information ofwhen and where the slide was found by noting which scanner read thebarcode and when it happened. Use of unique identifiers as describedherein allows for real time tracking as well as a convenient way tocreate a complete history of the slide with minimal input from a user.It is further contemplated that a network of laboratories can besimilarly equipped so that samples can be shared easily and effectively.

The invention may further include one or more of the followingembodiments. The unique identifier can be assigned at the moment thesample is removed from the patient's person. The unique identifier maybe assigned when the sample reaches the laboratory. It is furthercontemplated that scanners may be found throughout the facility, inareas not associated with equipment in the laboratory, such as a user'sdesk. In addition, while slides are the subject of this example, theyare only one example of the types of devices that can be used in theexamination of biological samples. Any device used to process biologicalsamples, such as tubes, cuvettes, vials, cassettes, biochips, andmicroplates, are also contemplated in the practice of the invention.Moreover, a user can be assigned an identifier. She can scan in heridentification when the sample is scanned so that the central databasecan record not only when and where the sample was scanned, but also whoscanned it in.

In another general aspect, the invention contemplates labels designed tohold information used in a laboratory equipped with scanners or otherdevices for inputting data into the system. The information may bepatient information and/or information concerning the tests to be run.The presence of the scanners reduces the need for a user to record thedata, as well as providing an efficient way to track the slides.

The details of one or more embodiments of the invention are set forth inthe accompanying drawings and the description below. Other features,objects, and advantages of the invention will be apparent from thedescription, drawings, and the claims.

DESCRIPTION OF DRAWINGS

FIG. 1 is a diagram of an exemplary organization of one embodiment ofthe invention.

FIG. 2 is a diagram of an exemplary architecture of one embodiment ofthe invention.

Like reference symbols in the various drawings indicate like elements.

DETAILED DESCRIPTION

In one aspect, a system for tracking the relevant samples andinformation is provided. It is designed to work for a single laboratoryor for a network of laboratories and clients. In other aspects, themethods and apparatus for tracking samples and information are alsoprovided. FIG. 1 shows one example of the flow of samples andinformation.

In this example, the identifier is a printed barcode number and thesample is a tissue to be analyzed under a microscope.

1) A sample bag is received at laboratory receiving 110. The sender mayhave already used an accession workstation 180, to enter informationinto the central database 200 about the sample, such as informationabout the source of the sample, patient information, the tests required,and the barcode number of the bag and each sample container. Theaccession workstation 180 can be local or it can be at a remotelocation, such as in the surgery room where the sample may have beencollected. Inputting information can also be done at the managementworkstation 120. The management workstation 120 can also allowconfiguration of all the instruments, as well as the laboratoryinformation system (LIS), provide additional information or updateinformation already in the system, and direct the processing of thesample.

2) A receiving clerk reads the bag barcode into the system. The clerkmay also read the barcode on the package. This information could belinked to the delivery service so that the receipt of the package isautomatically acknowledged to the delivery service. The central databasefinds the record of the shipment and displays a list of the expectedcontents for the clerk to check. If the individual samples do not havetheir own barcodes, the workstation can print them (as well as recordthe numbers).

3) At the grossing station 130, the technician shows the sample barcodesto the barcode reader and a screen displays a list of how the samplesare to be divided for the requested tests. Note that no paperdocumentation needs to follow the sample because from the sample'sunique identifier, the database can send, receive, and store the neededinformation. The sample may be subdivided into the needed number ofvials or cassettes, as the case may be. If these vials or cassettes areprelabeled with unique barcodes, the operator shows them to the readerwhen he is finished to note that they are in use, otherwise the systemassigns unique identifies to be affixed to the vial or cassettes. Theunique identifiers can be affixed in any way known in the art, such asby affixing a label to the slide or imprinting it into the slide.

4) At the microtome 140, the same process is repeated, the operatorshows the barcode of the cassette to the reader and a list appears ofhow many samples need to be cut for placement onto slides. Again, if theslides are not prelabeled, the station prints out the barcodes for theslides.

5) The labeled slides are loaded into an autostainer 150, which readsthe barcodes and checks the central database to see what stains need tobe applied to each slide.

6) Next, the slides are loaded in the automated microscope 160, whichreads the barcode to see what magnification and other parameters to useto scan the slide. Automated microscopes include ACIS (automated cellimage system) a device that scans the slides and presents images to thepathologist along with image processing tools to help in the diagnosticprocess. Apparatus for the automated analysis of samples are known inthe art, for example, they are described in U.S. Pat. Nos. 6,215,892;6,330,349; 6,418,236, the contents of which are incorporated byreference in their entirety.

7) Finally, an image is displayed to a pathologist who uses the imageprocessing features of the review workstation 170 to study the image andarrive at a diagnosis.

These diagnostic quality review workstations 170 display the imagescaptured by the image acquisition system. In order to assist thepathologist in interpreting a medical image, a view station may be ableto perform a variety of image processing operations on the medicalimage. For example, the pathologist at the view stations may invokealgorithms to perform densitometry on selected regions of the medicalimage in order to identify concentration of a particular analyte withinthe tissue sample. Other image processing operations are useful forfinding objects within the image such as the nuclei of the cells,computing an integrated optical density for the nuclei of the cells andreporting the number of molecules per cell. Most image processingoperations output a fixed number (score), often falling within apredetermined range. Demographic data about the patient, which wasirrelevant to the processing of the slide, might be fetched from thecentral database and displayed at this point.

Due to the size of some medical images for a single tissue sample,typically remote viewing is unworkable if there are bandwidthconstraints. Compression algorithms can produce an image suitable fortransmission, but the data lost during compression can lead toinaccurate results from the image analysis operations.

A system can be utilized in which a remote review workstation 170 iscommunicatively coupled to an image server and receives a compressedversion of a source medical image. The remote review workstation 170 canuncompress and display the received medical image. The compressedmedical image can be transmitted over a global packet-switched networksuch as the Internet. The remote review workstation 170 can select aregion of the displayed medical image as a function of input receivedfrom a user. Based on the input, the remote review workstation 170 cantransmit region information, such as a series of pixel coordinates, backto the image server. The image server can then apply image analysisoperations to a region of the source medical image that corresponds tothe selected region of the compressed medical image. In this manner, thedata loss that occurs during image compression does not affect the imageanalysis operations. As such, the image analysis operations can producemore accurate results than if the operations were applied by the remotereview workstation 170 on the compressed image. U.S. patent applicationSer. No. 09/542,091, filed Apr. 3, 2000, the contents of which areincorporated by reference, describes a system in which images are viewedat a site remote from the location of the ACIS microscope that collectsthe images. It further describes a method for carrying out the imageprocessing at a remote site that has uncompressed versions of the imageswhile transmitting compressed images for human viewing. Other means forviewing large images electronically are known to the skilled artisan.Therefore, in situations where the review workstation 170 is connectedto the system with a limited bandwidth, e.g., over the WAN, one methodfor transmitting data involves generating a compressed medical image,transmitting the compressed medical image to a remote view station fordisplay, selecting a region of the displayed medical image, and applyingimage analysis operations to a region of the source medical imagecorresponding to the selected region of the compressed medical imaged.The image displayed for review might be compressed, but the user'srequests for image processing or scoring algorithms might be sent backto the central database for execution on uncompressed images. However,if there is no need to review the images from a remote location, e.g.,over the LAN, then there is no reason not to send an uncompressed image.

An optional feature of the system can include users being assigned theirown identifying string, such as a barcoded badge. They can then log ontoany one of the stations by scanning their barcoded badge. One method ofutilizing the feature is to have the user log onto the station when theylog in a slide. The system can then provide information about who hashandled the slide at any given stage of its processing. This system canalso be used to assess the quality and quantity of work being handled byan individual.

Still other features of the system can include apparatus adapted for usein the system. For example, an autostainer may be designed to use itsbarcode reader to read IDs on the bottles of reagent to track whichslides are stained with which lot of reagent. A scanner, such as abarcode reader, on a refrigerator or other sample storage space can beused to check in or check out samples for tracking purposes. Anundedicated reader, for instance at a supervisor's station, could beused to identify a loose slide. It is contemplated that other equipmentgenerally found in laboratories, not herein described, can also beadapted to transmit information to and/or receive information from thedatabase to track and provide information about the sample or theprocess it undergoes.

The system takes advantage of being able to assign unique identifiers,and utilize scanners that read them, to faithfully transmit theinformation to a database. Each time a slide or sample passes throughsome station, the database can record this event. It is, therefore,possible to provide more detailed reports and tracking information withless effort then can be done with paper based systems. For instance, ifa slide is missing, the database can provide information about whichstation it was last logged in, when it was logged in and who logged itin, without a user having written any of this information into thesystem. If a batch of reagent becomes suspect, the database can provideinformation about all the samples that used the reagent and the testresults from that use. If a stat (rush) result is needed on a sample,the database can provide in real time information about where the sampleis in the process.

The system may utilize a centralized database. One of the benefits ofusing a centralized database is that it does not matter if some steps inthe processing of the sample occur at one facility and some at another.Since all the information is being stored in one database, someoneaccessing the database will see only the seamless processing of thesample. Furthermore, if a sample is sent from one facility to another,no paperwork need accompany it as long as the sample has its uniqueidentifier. When the sample arrives at the new facility, its uniqueidentifier can be scanned to log it in, to indicate its new location andwhen it arrived.

FIG. 2 shows a block diagram of a system in which clients (who havereview and accessioning workstations 310) are sending samples toreference laboratories 320 who are preparing slides and running them onan automated cell image system (ACIS). All of them are connected via theglobal Internet 330 to a data center 340, which is storing all theinformation. Table 1 shows an exemplary division of work in theapplication of an exemplary system.

TABLE 1 RL = CCIC reference lab 320 Client = CCIC client Sequence of CW= Client's workstation 310 Operation: DC = CCIC data center 340 ManualEvent Automatic Event For each Slide: Client enters acces- DC capturesaccessioning information sioning info DC sends accessioning info to RLClient sends DC center captures shipping information samples DC notifiesRL to expect shipment RL receives DC captures receiving informationshipment RL prepares slides RL ACIS sends lossless compressed images toDC RL scans slides on RL ACIS deletes images ACIS DC sends lossycompressed images to client DC notifies Client slides are ready forreview Client uses review CW sends region coordinates to DC analysisprogram to DC scores regions and sends scores back to CW view slides andselect regions Client releases cases CW prints report DC enters billingdata in database DC archives images if archive fee paid then deletesfrom hard disk At any time: Client requests case CW queries DC anddisplays results status on status dis- [if the RL had barcode readers atgrossing and play on Client sectioning, the display could indicate theexact stage workstation of each slide] Client requests re- CW queries DCon availability of operator review of archived CW informs client howlong tape mount will take case (if they have this service) DC operatormounts DC sends notification to Client tape Client reviews case

Although barcodes are referred to here, any globally unique system ofidentifiers could be used, for instance letters and numbers if OpticalCharacter Recognition (OCR) readers were used. An OCR system that candistinguish 80 symbols can detect 10 quintillion (a billion billion)different 10-character labels.

In the system, each label is unique and is used to identify theinformation sent to the database and/or retrieved from the database.This allows any part of the system (within one laboratory or in otherfacilities) to work on the samples or slides without having to re-labelfor use with different equipment or for different processing steps.

Other components of the system may include an autostainer and anautomated microscope that reads the same barcode and each extracts theinformation it needs from the database; a microtome with a barcodereader and printer, which can read the barcode on a cassette (block),look up in the database what tests are to be performed on slides cutfrom this block, and then print the required number of slide barcodes;and/or a grossing station that can read the barcode on a sample bag anddisplay a list of tests to be done on this sample for the guidance ofthe pathologist doing the grossing. It would then either print theneeded barcodes for the appropriate number of cassettes or sample tubesor otherwise encode the cassettes or samples. If they were prelabled itwould read the labels. In either case, it would automatically make therequired entries in the database to maintain the link between thepatient, sample, and the intermediate sample carriers.

A number of embodiments of the invention have been described.Nevertheless, it will be understood that various modifications may bemade without departing from the spirit and scope of the invention.Accordingly, other embodiments are within the scope of the followingclaims.

What is claimed is:
 1. A system for tracking and processing biologicaltissue samples, comprising: at least one central database configured toreceive and store information relating to a biological tissue sample;wherein the information comprises: processing steps to be carried out onthe biological tissue sample at different workstations; last knownlocation of the biological tissue sample; processing history of thebiological tissue sample; and reagent lot numbers used to process thebiological tissue sample; wherein each biological tissue sample thatwill be processed is associated with at least one unique bar codeidentifier, the biological tissue samples to be processed being ofunknown diagnosis, wherein the unique bar code identifier represents asequence of letters, numbers, symbols or combinations thereof, generatedby a unique identifier algorithm or is assigned sequentially, whereinthe at least one central database is configured to communicate with agrossing workstation, the grossing station being configured to producethe biological tissue samples of unknown diagnosis, and at least oneworkstation chosen from shipping workstations, receiving workstations,management workstations, accessioning workstations, microtomeworkstations, automated stainer workstations, automated microscopeworkstations, and review workstations, wherein the grossing workstationand the at least one workstation are configured to read the unique barcode identifier and to access, from the central database,workstation-specific tissue processing steps associated with the uniquebar code identifier, and a printer at the grossing workstation that isconfigured to automatically receive information from the centraldatabase, to automatically generate the unique bar code identifier forthe biological tissue sample, and to enable the unique bar codeidentifier to be affixed to a tissue cassette at the grossingworkstation.
 2. The system of claim 1 wherein the unique identifier is auniversally unique identifier (UUID) or a global unique identifier(GUID).
 3. The system of claim 1 further comprising a printer at themicrotome workstation, wherein the printer is configured toautomatically receive information from the central database, toautomatically generate the unique bar code identifier for the biologicaltissue sample and to enable the unique bar code identifier to be affixedto or imprinted on a microscope slide at the microtome workstation. 4.The system of claim 1 further comprising a bar code reader at themicrotome workstation, wherein the bar code reader is configured tocommunicate with the central database and to recognize the unique barcode identifier that is prelabeled or imprinted on a microscope slide.5. The system of claim 1 further comprising a bar code reader at thegrossing workstation, wherein the bar code reader is configured tocommunicate with the central database and to recognize the unique barcode identifier that is prelabeled or imprinted on the tissue cassette.6. A system for tracking and processing biological tissue samplescomprising: at least one central database configured to receive andstore information relating to a biological tissue sample; wherein theinformation comprises: processing steps to be carried out on thebiological tissue sample at different workstations, the processing stepsbeing configured to prepare the biological sample for diagnosis; lastknown location of the biological tissue sample; processing history ofthe biological tissue sample; and number of derived biological tissuesamples to be cut from the biological tissue sample; wherein eachbiological tissue sample that will be processed and each derivedbiological tissue sample is associated with at least one unique bar codeidentifier, wherein the unique bar code identifier represents a sequenceof letters, numbers, symbols or combinations thereof, generated by aunique identifier algorithm or is assigned sequentially; a workstationfor cutting the derived biological tissue samples from the biologicaltissue sample, wherein the workstation is configured to read the atleast one unique bar code identifier and communicate with the centraldatabase, and wherein, based on the at least one unique bar codeidentifier, the number of derived biological tissue samples to be cutfrom the biological tissue sample is displayed at the workstation. 7.The system of claim 6 wherein the first workstation is a grossingworkstation and the plurality of derived tissue samples is a pluralityof tissue blocks to be embedded in wax.
 8. The system of claim 6 whereinthe first workstation is a microtome workstation and the plurality ofderived tissue samples is a plurality of tissue sections to be placed onmicroscope slides.
 9. A system for tracking and processing biologicaltissue samples comprising: at least one central database configured toreceive and store information relating to a biological tissue sample;wherein the information comprises: processing steps to be carried out onthe biological tissue sample at different workstations, the processingsteps being configured to prepare the biological sample for diagnosis;last known location of the biological tissue sample; processing historyof the biological tissue sample; and reagent lot numbers used to processthe biological tissue sample; wherein each biological tissue sample thatwill be processed is associated with at least one unique bar codeidentifier, wherein the unique bar code identifier represents a sequenceof letters, numbers, symbols or combinations thereof, generated by aunique identifier algorithm or is assigned sequentially; an automatedstainer configured to communicate with the central database; anautomated slide image system configured to communicate with the centraldatabase; a microtome workstation configured to communicate with thecentral database; a first reader at the automated stainer, wherein thefirst reader is configured to read the unique bar code identifier, andwherein the unique bar code identifier is associated with at least oneprocessing step for the automated stainer, and wherein the at least oneprocessing step is displayed at the automated stainer; and a secondreader at the automated slide image system, wherein the second reader isconfigured to read the unique bar code identifier, and wherein theunique bar code identifier is associated with at least one processingstep for the automated slide image system.
 10. A system for tracking andprocessing biological tissue samples comprising: at least one centraldatabase configured to receive and store information relating to abiological tissue sample; wherein the information comprises: processingsteps to be carried out on the biological tissue sample at differentworkstations, the processing steps being configured to prepare thebiological sample for diagnosis; patient information; last knownlocation of the biological tissue sample; and processing history of thebiological tissue sample; wherein each biological tissue sample thatwill be processed is associated with at least one unique bar codeidentifier, wherein the unique bar code identifier represents a sequenceof letters, numbers, symbols or combinations thereof, generated by aunique identifier algorithm or is assigned sequentially; wherein the atleast one central database is configured to communicate with at leasttwo workstation chosen from shipping workstations, receivingworkstations, grossing workstations, management workstations,accessioning workstations; microtome workstations, automated stainerworkstations, automated microscope workstations, or review workstations;wherein the at least one central database is configured to communicatewith a laboratory information system (LIS); and wherein at least two ofthe workstations are configured to read the unique bar code identifierand to access, from the central database, workstation specificprocessing steps associated with the unique bar code identifier.
 11. Thesystem of claim 10 wherein the central database is accessible byauthorized users at remote sites.
 12. The system of claim 10 wherein atleast one first workstation is at a first laboratory and at least onesecond workstation is at a second laboratory.
 13. The system of claim 10wherein the accessioning workstation or the reviewing workstation is aremote workstation at a remote location from the central database or theother workstations.
 14. The system of claim 13 wherein the remoteworkstation is configured to communicate with the central database viathe Internet.
 15. A method of tracking and processing biological tissuesamples comprising: providing at least one central database thatreceives and stores information relating to a biological tissue sample;wherein the information comprises: at least one processing step to becarried out on the biological tissue sample, the at least one processingstep being configured to prepare the biological sample for diagnosis;number of derived biological tissue samples to be cut at differentworkstations; last known location of the biological tissue sample; andprocessing history of the biological tissue sample; wherein eachbiological tissue sample that will be processed is associated with atleast one unique bar code identifier, wherein the unique bar codeidentifier is a sequence of letters, numbers, symbols or combinationsthereof, generated by a unique identifier algorithm or is assignedsequentially and wherein the unique bar code identifier is used by thecentral database to access the information; assigning, to a first tissuesample, a first unique bar code identifier, where the first unique barcode identifier is associated with the information in the centraldatabase; providing a first workstation that recognizes the first uniquebar code identifier and retrieves from the central database and displaysthe number of derived samples to be cut at the first workstation basedon the first unique bar code identifier; cutting derived tissue samplesfrom at least one portion of the first tissue sample in accordance withthe number of derived tissue samples to be cut at the first workstation;and assigning a new unique bar code identifier to each derived tissuesample.
 16. The method of claim 15 further comprising: displaying, atthe first workstation, the number of derived tissue samples to be cut atthe first workstation.
 17. The method of claim 15 further comprising:reading at the first workstation, an operator identifier; andassociating the operator identifier with the information in the centraldatabase relating to the biological tissue sample.
 18. The method ofclaim 15 further comprising: placing the derived tissue samples intissue cassettes at a grossing workstation; and embedding the derivedtissue samples in wax.
 19. The method of claim 15 further comprising:placing the derived tissue samples in microscope slides at a microtomeworkstation.
 20. A method for tracking and processing biological tissuesamples, comprising: providing at least one central database thatreceives and stores information relating to a biological tissue sample,wherein the information comprises: tissue processing steps to be carriedout on the biological tissue sample at different workstations, theprocessing steps being configured to prepare the biological sample fordiagnosis; last known location of the biological tissue sample;processing history of the biological tissue sample; reagent lot numbersused to process the biological tissue sample; and assigning to eachbiological tissue sample that will be processed at least one unique barcode identifier, wherein the unique bar code identifier represents asequence of letters, numbers, symbols or combinations thereof, generatedby a unique identifier algorithm or is assigned sequentially; providingat least two workstations that are in communication with the at leastone central database, wherein the at least two workstations are chosenfrom shipping workstations, receiving workstations, grossingworkstations, management workstations, accessioning workstations,microtome workstations, automated stainer workstations, automatedmicroscope workstations, or review workstations; reading the unique barcode identifier at least two of the workstations to access workstationspecific processing steps in the central database; and displaying thetissue processing steps at one or more of the at least two workstations.21. The method of claim 20 further comprising: checking the database toconfirm that the workstation reading the unique bar code identifier isthe correct workstation to perform the next processing steps.
 22. Themethod of claim 20 further comprising: reading, at the firstworkstation, an operator identifier; and associating the operatoridentifier with the information in the central database relating to thebiological tissue sample.
 23. The method of claim 20 further comprising:reading the unique bar code identifier at the management workstation;and displaying, at the management workstation, information in thecentral database relating to the unique bar code identifier and thebiological tissue sample.
 24. The method of claim 23 wherein theinformation is a real-time location of the biological tissue sample or ahistorical location of the biological tissue sample.
 25. The method ofclaim 20 further comprising: retrieving, from the central database,unique identifiers associated with previous biological tissue samplesthat have been processed with a specific reagent lot number at thestainer workstation.
 26. A method of tracking and processing biologicaltissue, comprising: providing at least one central database thatreceives and stores information relating to a biological tissue sample;wherein the information comprises processing steps to be carried out onthe biological tissue sample, the processing steps being configured toprepare the biological sample for diagnosis; reagent lot numbers used toprocess the biological tissue sample; last known location of thebiological tissue sample; and processing history of the biologicaltissue sample; wherein each biological tissue sample that will beprocessed comprises at least one unique bar code identifier, wherein theunique bar code identifier is a sequence of letters, numbers, symbols orcombinations thereof, generated by a unique identifier algorithm or isassigned sequentially and wherein the unique bar code identifier is usedby the central database to access the information; providing, at amicrotome workstation, a first reader that recognizes unique bar codeidentifiers and communicates with the central database through anetwork; providing, at an automated stainer, a second reader thatrecognizes unique bar code identifiers and communicates with the centraldatabase through the network; providing, at an automated slide imagesystem, a third reader that recognizes unique identifiers andcommunicates with the central database through the network; assigning afirst unique bar code identifier to a first biological tissue sample,wherein the first biological sample is a tissue block, wherein the firstunique bar code identifier is associated with the information in thecentral database; recognizing the first unique bar code identifier withthe first reader and accessing, in the central database, based uponfirst the unique bar code identifier, a first set of processing stepsthat comprises at least one processing step for cutting a derived tissuesample from the tissue block; displaying the first set of processingsteps at the microtome workstation; cutting a derived tissue sample fromthe first tissue sample and assigning a new unique bar code identifierto the derived tissue sample; recognizing the new unique bar codeidentifier with the second reader and accessing in the central database,based upon the new unique bar code identifier, a second set ofprocessing steps that comprises at least one processing step forstaining the derived tissue sample on a microscope slide; automaticallystaining the derived tissue sample on the microscope slide in accordancewith the second set of processing steps; recognizing the new unique barcode identifier with the third reader and, based upon the new unique barcode identifier, accessing in the central database a third set ofprocessing steps that comprises at least one processing step for imagingthe derived tissue sample on the microscope slide; and automaticallyimaging the derived tissue sample on the microscope slide in accordancewith the third set of processing steps.
 27. A system for tracking andprocessing biological tissue samples comprising: at least one centraldatabase configured to receive and store information relating to abiological tissue sample; wherein the information comprises: processingsteps to be carried out on the biological tissue sample at differentworkstations, the processing steps being configured to prepare thebiological sample for diagnosis; last known location of the biologicaltissue sample; processing history of the biological tissue sample; andreagent lot numbers used to process the biological tissue sample;wherein each biological tissue sample that will be processed isassociated with at least one unique bar code identifier, wherein theunique bar code identifier represents a sequence of letters, numbers,symbols or combinations thereof, generated by a unique identifieralgorithm or is assigned sequentially; wherein the at least one centraldatabase is configured to communicate with at least two workstationschosen from shipping workstations, receiving workstations, grossingworkstations, management workstations, accessioning workstations;microtome workstations, automated stainer workstations, automatedmicroscope workstations, and review workstations; and, wherein the atleast two workstations are configured to read the unique bar codeidentifier and to access, from the central database, workstationspecific processing steps associated with the unique bar codeidentifier.
 28. The system of claim 27 wherein the unique identifier isa universally unique identifier (UUID) or a global unique identifier(GUID).
 29. The system of claim 27 further comprising a printer at themicrotome workstation, wherein the printer is configured toautomatically receive information from the central database, toautomatically generate the unique bar code identifier for the biologicaltissue sample and to enable the unique bar code identifier to be affixedto or imprinted on a microscope slide at the microtome workstation. 30.The system of claim 27 further comprising a bar code reader at themicrotome workstation, wherein the bar code reader is configured tocommunicate with the central database and to recognize the unique barcode identifier that is prelabeled or imprinted on a microscope slide.31. The system of claim 27 further comprising a printer at the grossingworkstation, wherein the printer is configured to automatically receiveinformation from the central database, to automatically generate theunique bar code identifier for the biological tissue sample and toenable the unique bar code identifier to be affixed to a tissue cassetteat the grossing workstation.
 32. The system of claim 27 furthercomprising a bar code reader at the grossing workstation, wherein thebar code reader is configured to communicate with the central databaseand to recognize the unique bar code identifier that is prelabeled orimprinted on a tissue cassette.